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AstraZeneca PLC on Wednesday said it won two new drug approvals in the European Union for Imfinzi and Lynparza to treat cancer.
The Cambridge-based pharmaceutical company’s drug Lynparza, made with its pharmaceutical peer Merck & Co Inc, has been approved as a combination treatment for metastatic castration-resistant prostate cancer. AstraZeneca said the treatment is for adult men for whom chemotherapy is not clinically indicated.
The approval is based on the results from its Propel phase three trial. The trial found that Lynparza, in combination with the abiraterone and prednisone or prednisolone medicines, reduced the risk of disease progression or death by 34%, compared to just abiraterone and prednisone or prednisolone.
‘The combination of Lynparza with abiraterone as a first-line treatment expands the use of Lynparza to a broader group of metastatic castration-resistant prostate cancer patients than those treated with Lynparza alone in the second-line setting in the Profound trial,’ said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology business unit.
AstraZeneca added its Imfinzi drug has also been approved as a first-line treatment for adults with unresectable or metastatic biliary tract cancer, in combination with chemotherapy.
The approval is based on primary results from the Topaz-1 phase three trial, which found Imfinzi with chemotherapy reduced the risk of death by 20%, compared to chemotherapy alone.
Results from the trial after a further 6.5 months of follow-up showed a 24% reduction in the risk of death. AstraZeneca said over two times as many patients treated with Imfinzi plus chemotherapy are estimated to be alive at two years, compared to 12% of patients taking chemotherapy alone.
Fredrickson added: ‘With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer. This approval underscores our commitment to transform survival outcomes while addressing the high unmet need for new and improved treatments for patients with hepatobiliary cancers.’
Shares in AstraZeneca were up 0.1% to 11,134.00 pence on Wednesday morning in London.
By Jaskeet Briah, Alliance News reporter
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